Dengue FeverNCT06843226
A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
An observational study of Dengue Fever, run by Takeda at 7 sites in 3 countries.
Trial summary
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue Fever
- How many people
- 70,000 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 5 Mar 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric and/or adolescent residents in the study area who are age-eligible for vaccination with TDV as part of a pilot public vaccination program (children 7-10 years in Thailand, 6-10 years in Indonesia, and 7-12 years in Malaysia).
Who may be able to join
- Cohort:
- To be eligible for inclusion in the study cohort, participants must meet the following inclusion criteria:
- The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
- The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort.
- The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written informed consent form (ICF), and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
- The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
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- The participant's parent(s) or LAR agrees that a baseline blood sample may be taken from the participant.
- Cases:
- To be eligible for inclusion as a case, participants must meet the following inclusion criteria:
- The participant is part of the cohort.
- The participant is hospitalized and clinically diagnosed with dengue.
- The participant has a blood sample available that was taken preferably within 5 days of fever onset and/or onset of symptoms compatible with dengue.
- The participant tested positive for dengue by RT-PCR.
- Controls:
- To be eligible for inclusion as a matched control, participants must meet the following inclusion criteria:
- The participant is part of the cohort.
- The participant had not been hospitalized with VCD at any point between enrollment in the cohort and the index date (that is, when his/her matched case was hospitalized with CDD).
- The participant is a resident in the same neighbourhood as the matched case.
- The participant's date of birth is in the same calendar year as the matched case.
Who cannot join
- Cases:
- To be eligible for inclusion as a case participants must not meet any of the following criteria:
- The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
- Contraindications as per the locally approved label/product information leaflet.
- Controls:
- To be eligible for inclusion as a control participants must not meet any of the following criteria:
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- The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
- Contraindications as per the locally approved label/product information leaflet.
- The participant could not be contacted at the time of being selected as a control.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Indonesia3 sites, 3 recruiting
- Recruiting
Fakultas Kedokteran Lambung Mangkurat
Banjarmasin, South Kalimantan, 70122
Site Contact, +62 8125172973, edihartoyo@ulm.ac.id
Edi Hartoyo
- Recruiting
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, 10430
Site Contact, +62 8551140441, nina.dwi@petridish-id.org
Nina Dwi Putri
- Recruiting
Fakultas Kedokteran Universitas Sriwijaya
Palembang, South Sumatra, 30662
Site Contact, +62 811713162, yuliairiani@fk.unsri.ac.id
Site Contact, +62 7113733438, a.karmila@unsri.ac.id
Thailand3 sites
- Active, not recruiting
Pattaya Patamakhun Hospital
Chon Buri, 20150
- Active, not recruiting
Nakhon Phanom Hospital
Nakhon Phanom, 48000
- Active, not recruiting
Phra Nakhon Si Ayutthaya Hospital
Phra Nakhon Si Ayutthaya, 13000
Malaysia1 site, 1 recruiting
- Not yet recruiting
Universiti Malaya Medical Centre
Kuala Lumpur, 59100
Site Contact, +60 125159447, rafdzah@ummc.edu.my
Rafdzah Ahmad Zaki
About this study
Official title: The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use.
The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).
- Conditions
- Dengue Fever
- Being tested
- No Intervention
- Keywords
- Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Nested Case-control Participants | The cohort will include case and control participants. Case participants who are hospitalized and meet the study inclusion and exclusion criteria for cases, have CDD, and have a confirmed positive RT-PCR test result (VCD) will be ascertained by active hospital surveillance.
Control participants who are matched to a case and meet the study inclusion and exclusion criteria for controls but have not been hospitalized with VCD on or before their case's index date (first date of hospitalization for CDD for potential cases) will be interviewed. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants.
Measured: Up to Month 36
Secondary outcomes (3)
Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD with each infecting dengue serotype (dengue virus [DENV]-1, DENV-2, DENV-3, and DENV-4) in unvaccinated and fully vaccinated participants will be reported.
Measured: Up to Month 36
Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD with dengue serostatus (seronegative and seropositive) of any dengue serotype in unvaccinated and fully vaccinated participants will be reported.
Measured: Up to Month 36
Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD by each infecting dengue serotype and baseline dengue serostatus (DENV-1 in baseline seronegative, DENV-2 in baseline seronegative, DENV-3 in baseline seronegative, DENV-4 in baseline seronegative, DENV-1 in baseline seropositive, DENV-2 in baseline seropositive, DENV-3 in baseline seropositive, and DENV-4 in baseline seropositive) in unvaccinated and fully vaccinated participants will be reported.
Measured: Up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start5 Mar 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843226
- Sponsor's protocol ID
- DEN-401
- Other IDs
- EUPAS1000000218
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study
- ClinicalTrials.gov ID
- NCT06843226
- Acronym / sponsor ID
- DEN-401
- Conditions
- Dengue Fever
- Keywords
- Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use.
The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nested Case-control Participants | – | Other: No InterventionThe cohort will include case and control participants. Case participants who are hospitalized and meet the study inclusion and exclusion criteria for cases, have CDD, and have a confirmed positive RT-PCR test result (VCD) will be ascertained by active hospital surveillance. Control participants who are matched to a case and meet the study inclusion and exclusion criteria for controls but have not been hospitalized with VCD on or before their case's index date (first date of hospitalization for CDD for potential cases) will be interviewed. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric and/or adolescent residents in the study area who are age-eligible for vaccination with TDV as part of a pilot public vaccination program (children 7-10 years in Thailand, 6-10 years in Indonesia, and 7-12 years in Malaysia).
Key inclusion criteria (19 listed)
- To be eligible for inclusion in the study cohort, participants must meet the following inclusion criteria:
- The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
- The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort.
- The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written informed consent form (ICF), and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
- The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
Key exclusion criteria (9 listed)
- To be eligible for inclusion as a case participants must not meet any of the following criteria:
- The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
- Contraindications as per the locally approved label/product information leaflet.
- To be eligible for inclusion as a control participants must not meet any of the following criteria:
- The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Nested Case-control Participants |
Primary outcome
Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Time frame: Up to Month 36
Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants.
3 secondary outcomes
Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants
Time frame: Up to Month 36
Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Time frame: Up to Month 36
Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants
Time frame: Up to Month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Fever, run by Takeda at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Indonesia, Thailand, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants (time frame: Up to Month 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.